7
Oct2016

PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.” Read more

4
Oct2016

Meet Cate Alexander, Research Compliance Manager & IRB Administrator at Kaiser Permanente in Honolulu, HI. She is highlighted this month as a part of our featured member interviews, which aim to share the experiences of individuals within our membership who are making an impact on the research ethics field through their work. 

PRIM&R: When and why did you join the field?
Cate Alexander (CA): Like a lot of folks, I fell into research compliance quite by accident. I started out at a central IRB in 1999 and instantly fell in love with the mission, the ethics, and the passion that people had; I was hooked. Over the [...] Read more

30
Sep2016

This week’s Research Ethics Roundup covers new ClinicalTrials.gov reporting requirements, the Cancer Moonshot panel’s recommendations, the Max Planck Institute’s sad discovery, and how European researchers are educating the public on nonhuman primate research. Read more

23
Sep2016

In February, PRIM&R began implementing its latest Strategic Plan. While we have had several such plans in our 40-plus year history, this plan is especially important in my mind. 

Research is fraught with a number of pressing issues today:  Rapid changes in research technologies and methodologies; rising concerns about privacy and the use of big data; tighter research budgets; the growth of patient- and public-centered approaches to research; ; the movement toward single IRBs—to say nothing of the impending impact of a new Common Rule, should one be announced—all make for a dynamic research landscape.

You can read more about PRIM&R’s Read more

22
Sep2016

Imagine this scenario: you are a researcher conducting a clinical trial on a promising treatment for a rare but serious heart condition. Unfortunately, you are struggling to locate and enroll enough eligible participants and your study is at risk of not completing. Then you discover a Facebook support group for precisely the condition you are studying. The group is open: you do not need to be invited or to suffer from the condition to become a member—anyone can join. Here are the eligible participants you have been looking for! Read more